Effects of Two Sugar Substituted Chewing Gums on Caries and Gingivitis Variables
Primary Purpose
Dental Plaque, Saliva Altered, Gingivitis
Status
Completed
Phase
Phase 4
Locations
Colombia
Study Type
Interventional
Intervention
xylitol
casein phosphopeptide amorphous calcium phosphate complex
Sponsored by
About this trial
This is an interventional prevention trial for Dental Plaque focused on measuring prevention & control, Xylitol, casein phosphopeptide amorphous calcium phosphate complex, Streptococcus mutans, saliva, dental plaque, gingivitis
Eligibility Criteria
Inclusion Criteria:
- systemically healthy
- dental student
Exclusion Criteria:
- less than 26 teeth in mouth
- use of orthodontic appliances
- use of antibiotics the last 3 months
Sites / Locations
- Facultad de Odontología, Universidad de Antioquia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
sugar substituted chewing gum A
Sugar substituted chewing gum B
Arm Description
Outcomes
Primary Outcome Measures
Turesky index
dental plaque assessment
Secondary Outcome Measures
Gingival index
gingival inflammation
salivary pH
Streptococcus mutans
number of Streptococcus mutans in saliva
Ca levels
levels of calcium in saliva
facultative microorganisms
number of facultative microorganisms in saliva
Lactobacillus
levels of Lactobacillus spp. in saliva
phosphate levels
inorganic phosphate leves in saliva
BOP index
bleeding on probing
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01578603
Brief Title
Effects of Two Sugar Substituted Chewing Gums on Caries and Gingivitis Variables
Official Title
Effects of Two Sugar Substituted Chewing Gums Plus Tooth Brushing on Different Caries and Gingivitis Related Variables: a Double Blind, Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Antioquia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the effect of three times a day mastication, during a follow-up period of 4 weeks, of two sugar-substituted chewing gums on various factors associated with dental caries and gingivitis.
Detailed Description
The purpose of this paper is to compare the effect of daily consumption of two sugar-free chewing gum, one with Recaldent and one with Xylitol, added to traditional hygiene (brushing, fluoridated toothpaste and dental floss), in clinical features such as the accumulation of plaque and gingival inflammation, microbiological characteristics of saliva as the counts of cariogenic microorganisms and facultative anaerobes, and some physicochemical properties of saliva such as pH and concentrations of calcium and inorganic phosphate.
To this there was a general call among dental students at the University of Antioquia and those who expressed their intention to participate voluntarily with informed consent, were examined clinically and randomly assigned to one of the study groups (Recaldent or Xylitol) or the control group.
After a month of baseline examination and the daily use of the same instruments of oral hygiene and chewing of 6 pellets of each chewing gum (in the case of study groups), all variables are re-examined.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque, Saliva Altered, Gingivitis
Keywords
prevention & control, Xylitol, casein phosphopeptide amorphous calcium phosphate complex, Streptococcus mutans, saliva, dental plaque, gingivitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sugar substituted chewing gum A
Arm Type
Experimental
Arm Title
Sugar substituted chewing gum B
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
xylitol
Other Intervention Name(s)
sugar alcohol
Intervention Description
6 g/day, for a month, by chewing 2g three times daily after meals.
Intervention Type
Dietary Supplement
Intervention Name(s)
casein phosphopeptide amorphous calcium phosphate complex
Other Intervention Name(s)
CPP-ACP complex
Intervention Description
two pieces of the commercial presentation three times daily after meals
Primary Outcome Measure Information:
Title
Turesky index
Description
dental plaque assessment
Time Frame
a month
Secondary Outcome Measure Information:
Title
Gingival index
Description
gingival inflammation
Time Frame
a month
Title
salivary pH
Time Frame
a month
Title
Streptococcus mutans
Description
number of Streptococcus mutans in saliva
Time Frame
a month
Title
Ca levels
Description
levels of calcium in saliva
Time Frame
a month
Title
facultative microorganisms
Description
number of facultative microorganisms in saliva
Time Frame
a month
Title
Lactobacillus
Description
levels of Lactobacillus spp. in saliva
Time Frame
a month
Title
phosphate levels
Description
inorganic phosphate leves in saliva
Time Frame
a month
Title
BOP index
Description
bleeding on probing
Time Frame
a month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
34 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
systemically healthy
dental student
Exclusion Criteria:
less than 26 teeth in mouth
use of orthodontic appliances
use of antibiotics the last 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria C Martínez-Pabón, MsC Microb
Organizational Affiliation
Universidad de Antioquia
Official's Role
Study Director
Facility Information:
Facility Name
Facultad de Odontología, Universidad de Antioquia
City
Medellín
State/Province
Antioquia
Country
Colombia
12. IPD Sharing Statement
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Effects of Two Sugar Substituted Chewing Gums on Caries and Gingivitis Variables
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